Innovative Capsule Filling From Molecule to Market: New Flexible Solutions for Solid Dosage Capsules
Following the rising demand for active substances processed in contained environments, Penn Pharma decided to equip its new contained manufacturing operations with a GKF HiProTect from Bosch Packaging Technology. The capsule filling machine is especially designed for processing highly potent substances and enables safe and flexible capsule manufacturing technology.
The number of potent pharmaceutical compounds requiring solid dosage development and subsequent manufacture at clinical and commercial scale is growing at a rapid pace. This process calls for contained environments to protect machine operators and products from crosscontamination.
A containment system prevents biological agents from escaping either into the working surroundings or the external environment. Containment requires closed containers or biological cabinets and the use of rooms with specially designed air handling units and secures operating procedures.
From Molecule to Market
Penn Pharma, one of the longest established pharmaceutical services companies, sees one of its main assets as being able to operate at both a development and commercial scale. The company’s international projects have led to a significant experience in working and complying with the major regulatory bodies in Europe, the US and Japan. An important component for the company’s success is the use of state-of-the-future equipment with highest safety standards. This was also one of the main requirements when it decided to expand its production facility and started looking for a new containment capsule filling machine.
“We are seeing growth in the number of highly potent molecules coming through clinical pipelines. To meet these rising demands, we have invested in expanding our existing resources. Our vision is to become the preferred partner for the supply of solid oral doses containing potent molecules for both investigational and commercial use,” says CEO, Penn Pharma, Richard Yarwood.
Safety Meets Flexibility
“We ran a comprehensive supplier bidding process which used over twenty different and weighted selection criteria, before shortlisting potential suppliers,” avers COO, Penn Pharma, Mark Dean-Netscher. “Owing to the very serious nature of our investment in handling highly potent drug molecules, we needed to implement an engineering solution that puts employee safety, regulatory compliance and reproductive batch scale that is central to our design philosophy,” he continues. After a number of supplier presentations, the GKF HiProTect was found to meet all these criteria.